BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 2964522 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00435
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    February 20, 2008
    Report Date
    December 20, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POCKET HEMATOMA. THE PATIENT UNDERWENT POCKET REVISION AND THE DEVICE REMAINED IN USE. THE PATIENT IS ENROLLED IN THE (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68468 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R